Tuesday, January 11, 2011

Merck's Janumet® FDA Filing: Still Playing "Catch Up" To Kombiglyze XR®

In early November 2010, I noted a Merck stock price decline occasioned by the lunch-time FDA approval of Bristol-Myers-Squibb and AstraZeneca's Kombiglyze® XR, which was approved by FDA for Type II Diabetis. That novel combination brings together an extended-release version of the metformin diabetis drug (also in Merck's Janumet) with the companies’ Onglyza® (Saxagliptin). Onglyza was, in turn, cleared for U.S. sales in July 2010. Kombiglyze was approved by the U.S. Food and Drug Administration to treat patients with Type II diabetis, the companies said in a statement in November 2010, thus: "Kombiglyze XR combines two effective diabetes medications in a simple once-a-day dose. . . ."

Now, about a quarter later, New Merck is just making its initial new drug application filing with FDA -- for what it hopes will be a competing once-a-day regimen for Type II diabetis. Here is this morning's presser, out of Whitehouse Station:

. . . .The extended-release formulation of JANUMET is an investigational treatment for type 2 diabetes that combines sitagliptin, which is the active component of Januvia® (sitagliptin), with metformin extended release, a commonly-prescribed medication for type 2 diabetes, into a single tablet. This formulation is designed to provide a new treatment option for healthcare providers and patients who need two or more oral agents to help control their blood sugar with the convenience of once daily dosing. . . .

So -- Saxagliptin/Metformin (now available), or Sitagliptin/Metformin (available in late 2011, at the earliest)?

Obviously, the problem here is that Kombiglyze XR already does this job quite well, and it will have about a year's lead on Janumet -- in the all-important US markets.

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